Democrat Seeks to Close 510(k) ‘Loophole’

A new report from Congressman Edward J. Markey (D-MA) urges 510(k) reforms to close what he calls a “loophole” that exposes patients to potentially unsafe medical devices. The report, "Defective Devices, Destroyed Lives: Loophole Leaves Patients Unprotected from Flawed Medical Devices," highlights the loophole as allowing FDA to clear medical devices that demonstrate equivalence to an earlier model (predicate), even if that previous model was recalled for a major safety defect. “This loophole in the 510(k) device approval process – named after its section in the law – has enabled a number of defective products to enter the market and cause serious harm, and in some cases even death,” he said.

In February, Markey introduced H.R. 3847, the Safety Of Untested and New Devices Act (SOUND) of 2012 to close this regulatory loophole and ensure that new medical devices are not cleared by FDA if they are based on an product that was recalled. He said he is urging fellow lawmakers to add the bill to the user fee reauthorization measure being considered this summer.